Exec Chat: Medtronic’s Goodheart Talks About COVID, AI, Diversity, TAVR And More
Medtech Insight sat down with Nina Goodheart, the president of Medtronic’s structural heart and aortic operating unit, to learn more about her experience with the company during the pandemic, the company’s commitment to diversity and inclusion, and the future of structural heart technology.
As the market for transcatheter valve devices continues to grow, structural heart devices have become one of Medtronic’s strengths.
Sales of its transcatheter valves grew 11% globally in the first quarter of fiscal 2024 (calendar May to July 2023), led by rapid adoption of Evolut FX, the fourth generation of Medtronic’s successful CoreValve transcatheter aortic valve replacement (TAVR) system. (Also see "News We’re Watching: Illumina Looks At Grail Options, New AdvaMed Digital Health Division, Evolut FX Gets CE Mark" - Medtech Insight, 13 Oct, 2023.)
Medtronic’s structural and aortic business is a relatively new division created as part of the overall restructuring of the company initiated by CEO Geoff Martha in 2020. (Also see "Medtronic Lays Out Plans To Achieve 5%+ Annual Growth" - Medtech Insight, 15 Oct, 2020.)
Since 2021, the business has been led by Nina Goodheart, who has been with the company since 2007. She is an advocate for diversity and inclusion within Medtronic and is helping Medtronic find new ways to bring medical technology to underserved populations.
Goodheart recently talked to Medtech Insight about her commitment to Medtronic, where she sees the business going in the coming years, and more.
When I graduated from grad school at NYU, I worked for a number of advertising agencies. I then did some consulting work, both in Big Pharma and then in medtech and became exposed to Medtronic. I think when you get to this company, it has a different feel to it.
We've got this incredible mission, about alleviating pain, restoring health, and extending life. And when yousee that in action – because that's really the way we respond to the market – with the direct impact that we have on patients, it's quite incredible. And it is compelling and it's gratifying that it holds people here.
I know it's helped me and kept me here for a long time.
He wanted to simplify what was a very complicated organization of 95,000-plus people. We created operating units that are very focused on the individual businesses and getting senior leaders closer to the businesses that they run. This puts the operating units at the center of what we do at Medtronic.
The operating units are focused on growth and focused on bringing new technologies into our individual markets. All of that has gone well. We've focused on how to ‘play big’ and how to use the breadth and the scale of Medtronic where that's warranted.
But we also ‘play small,’ thinking about each of these individual businesses that bring technology into those individual markets, and make sure that we've got a strong focus on those businesses.
We're still doing some work; it's still relatively new. We're refining our operating mechanisms, etc. But the crux of what we're trying to accomplish has been very well received and is going well.
"We created operating units that are very focused on the individual businesses and getting senior leaders closer to the businesses that they run." – Nina Goodheart
I think this specific operating model has helped, even in COVID, to get everyone closer to the businesses that we’re either running or that we are a part of.
In my operating unit, we have focused a lot on communication, especially during COVID when we weren't all together. We’ve made sure that we've got timely, transparent communication and that we have dialogues of communication going both ways.
This ensures people understand what was happening and that they are empowered in their decision making. How do we push decision making down into the organization so the people closest to the work are making decisions about the work? That is what we've been focusing on.
To your specific question, in regard to clinical trials, I think about how we use AI with EMRs, for instance, to identify patients at risk, identify physicians who are part of clinical trials, and match those up to expand those patient cohorts.
We also think about pre-procedure planning; How do we use AI to enable better imaging and better planning prior to the procedure and post-procedure, so that we start to make all of that go much more quickly and standardized in a way that benefits patients?
There's so much in front of us when it comes to AI. We are just beginning to tap into it.
In all areas of medicine – not just cardiology – clinical trials have been focused on enrolling men. But we create a public health issue if we ignore 50% of the population, so it's critical that we focus on ensuring that we've got the entire population enrolled in clinical trials and that we understand the differences, if there are any, between men and women in any specific area of medicine. (Also see "National Academies Join Call For More Diversity In Trials" - Medtech Insight, 20 May, 2022.)
As you may be aware, we're running a trial called the SMART trial, a head-to-head transcatheter aortic valve trial in patients with small annuli, which will primarily be women. (Also see "Medtronic Announces Two New Trials To Expand TAVR Indications" - Medtech Insight, 19 Oct, 2020.)
Women will be significantly represented in that clinical trial. And then we'll be able to see the impact of technologies on women with valve disease. We'll be presenting the results of that trial this spring and we're all really excited to see what that shows.
"We're just scratching the surface. There is an enormous opportunity to bring these technologies to more patients." – Nina Goodheart
There are still a large number of patients around the world who have aortic stenosis and who still don't have the opportunity for TAVR. So we think about access – women, underserved and underrepresented communities, Hispanics, African Americans, etc.
We know that the penetration of TAVR in those communities is significantly lower than the population at large. That's an enormous opportunity for TAVR. How do we bring this technology to new areas around the world?
We just recently launched the Medtronic TAVR technology in China, for example, but there are still a lot of places around the world where we haven't yet launched this technology There's still lot of geographic expansion needed, but we are still pursuing new indication expansions.
TAVR is indicated for severe, symptomatic aortic stenosis, there's also moderate and asymptomatic aortic stenosis. There are all kinds of areas still to be penetrated with TAVR.. And there are lots of additional opportunities, both in mitral replacement and mitral repair and tricuspid repair.
When I think about the structural heart space, we're just scratching the surface. There is an enormous opportunity to bring these technologies to more patients.
"We have amazing teams at Medtronic, and I'm proud of the work they've done across all four of our valve programs to bring these life changing technologies to market." – Nina Goodheart
But there are a lot of areas where there's not a TAVR center but there is a surgical program, so there is the opportunity to put in a TAVR center, especially in underrepresented communities.
We're doing pilot programs, especially in the southeast part of the United States in a couple of key areas, looking at where there is very low penetration of TAVR and a high, underserved population, and looking to see how we engage more physicians in those areas in clinical trials.
How do we create more shared decision-making tools so that patients have a better understanding of the opportunities? And how do we bring those things together so that we can have a higher penetration into some of those underserved communities?
And, to be a structural heart program, you have to have programs in all four heart valves. We just recently launched a transcatheter pulmonary valve called Harmony for pediatric and adult patients. (Also see "Two-Year Results Support Medtronic’s Harmony Transcatheter Pulmonary Valve System" - Medtech Insight, 14 Jun, 2023.)
That has been phenomenally successful. It is amazing to be able to treat these young patients. Now they have the opportunity for a great, healthy life. And because these technologies have been so successful in children and young people, there are now adults living with congenital heart disease that will have ongoing treatment needs. We recently introduced this technology in the U.S. and Japan with more launches coming to help patients around the world.
We have amazing teams at Medtronic, and I'm proud of the work they've done across all four of our valve programs to bring these life changing technologies to market.